The following data is part of a premarket notification filed by Endochoice, Inc. with the FDA for Fuse 1c Colonoscopy System.
| Device ID | K132839 |
| 510k Number | K132839 |
| Device Name: | FUSE 1C COLONOSCOPY SYSTEM |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | ENDOCHOICE, INC. 11810 WILLS ROAD Alpharetta, GA 30009 |
| Contact | Daniel Hoefer |
| Correspondent | Daniel Hoefer ENDOCHOICE, INC. 11810 WILLS ROAD Alpharetta, GA 30009 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-10 |
| Decision Date | 2014-02-06 |
| Summary: | summary |